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Acute Leukemia | Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy

Acute Leukemia research study

What is the primary objective of this study?

Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy. Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during treatment reported by paediatric cancer survivors. Complete prevention of both nausea and vomiting is the goal of anti-vomiting and nausea medications. It is important to understand whether or not certain chemotherapeutic treatments are more or less likely to cause these symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal methotrexate is an important part of chemotherapy for the prevention and treatment of central nervous system leukemia over the 2.5 to 3.5 years of the treatment program for leukemia. The likelihood that intrathecal methotrexate administered as monotherapy will cause nausea and vomiting has not yet been described in children. Knowledge of the likelihood that intrathecal methotrexate will cause nausea and vomiting will therefore be important to optimize treatment for these side-effects of chemotherapy. The primary aim of this prospective study is to evaluate the potential of intrathecal methotrexate to cause nausea and vomiting in paediatric cancer patients.

Who is eligible to participate?

Inclusion Criteria: - 4 years old to 18 years of age (age range in which the PeNAT has been validated) [18] - English speaking (PeNAT has been validated only in English) - Cognitive ability of the child believed to be at least at a 4 year old level according to parent or health care professional - Patients are past their first cycle of maintenance therapy to avoid interactions with the intensive chemotherapy phase. Exclusion Criteria: - Receiving chemotherapy other than dictated by protocol for maintenance therapy within 24 hours prior to or 24 hours following receipt of intrathecal methotrexate

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Leukemia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Acute LeukemiaChildren diagnosed with acute leukemia, undergoing chemotherapy. Patients with acute leukemia will receive intrathecal methotrexate on day 1 plus intravenous vincristine on day 1 plus oral steroid on days 1-5 plus their regularly scheduled and ongoing daily oral 6-mercaptopurine at the start of a maintenance therapy cycle.

Study Status

Unknown status

Start Date: July 2012

Completed Date:

Phase: N/A

Type: Observational

Design:

Primary Outcome: Acute Chemotherapy-Induced Nausea and Vomiting

Secondary Outcome: Anticipatory Chemotherapy-Induced Nausea and Vomiting

Study sponsors, principal investigator, and references

Principal Investigator: Angela Punnett, MD

Lead Sponsor: The Hospital for Sick Children

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01661413

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